MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-13 for 4 FR POWERWAND MIDLINE CATHETER 94103 manufactured by Access Scientific, Llc.
| Report Number | MW5087362 |
| MDR Report Key | 8699908 |
| Date Received | 2019-06-13 |
| Date of Report | 2019-06-11 |
| Date of Event | 2019-06-05 |
| Date Added to Maude | 2019-06-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 4 FR POWERWAND MIDLINE CATHETER |
| Generic Name | PERIPHERAL CATHETER INSERTION KIT |
| Product Code | OWL |
| Date Received | 2019-06-13 |
| Returned To Mfg | 2019-06-11 |
| Model Number | 94103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCESS SCIENTIFIC, LLC |
| Manufacturer Address | 3910 SORRENTO VALLEY, 200 CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-06-13 |